A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)

Completed

• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Interventions: Biological: Nivolumab

• Registration Number: NCT05068609
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.

Detailed Description

This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration. The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab. Eligible participants will be enrolled and observed from enrollment up to eight weeks. Demographic and clinical characteristics will be collected at enrollment. PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.

Study Timeline

• Study Start: 2020-08-13
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Primary Completion: 2021-10-18
• Study Completion: 2021-10-18
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

Inclusion Criteria

• Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)
• Age ≥18 years at time of nivolumab treatment initiation
• Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study
• Charts/records include treatment start date of nivolumab
• Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion

Exclusion Criteria

• Currently enrolled in an interventional clinical trial for their SCCHN
• Received systemic treatment for any other primary cancer within 6 months of study enrolment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Nivolumab	Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab

Primary Outcome Measures

Name	Time	Method
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth	At enrollment	Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \& Neck (SCCHN)
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex	At enrollment
Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN	At enrollment, Up to 8 weeks	Cancer Therapy Satisfaction Questionnaire (CTSQ)
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status	At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity	At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location	At enrollment
Distribution of patient reported health-related quality of life (HRQoL) measures through European Organisation for Research and Treatment of Cancer Quality of Life- Core Questionnaire in participants treated with nivolumab for R/M SCCHN	At enrollment, Up to 8 weeks
Distribution of patient reported HRQoL measures through European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module in participants treated with nivolumab for R/M SCCHN	At enrollment, Up to 8 weeks
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations	At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis	At enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy	Up to 8 weeks following enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation	Up to 8 weeks following enrollment
Distribution of subsequent treatment in participants discontinuing nivolumab	Up to 8 weeks following enrollment
Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN	At enrollment, Up to 8 weeks
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology	At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN	At enrollment
Distribution of doses of nivolumab therapy in participants with R/M SCCHN	Up to 8 weeks following enrollment
Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN	At enrollment, Up to 8 weeks	Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Mount Laurel, New Jersey, United States